Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

This study has been completed.

Sponsor:

OrthoAccel Technologies Inc.

ClinicalTrials.gov Identifier:

NCT00830947

First Posted: January 28, 2009

Last Update Posted: December 23, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Sham device will look identical to active devices but will not deliver vibration to the patient.

Device: Sham Device

Inactive sham device that is held in the mouth for 20 minutes.

Detailed Description:

This is a randomized, blinded study that will follow 32 patients for up to six months. Patients will have a minimum of 3 mm of extraction space that needs to be closed by moving the anterior teeth or canine distally. Patients will have standard orthodontic treatment and temporary anchorage devices for tooth movement and space closure. Half the patients will receive a functioning device and half the patients will receive a sham-device. Patients will use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly bite into plus a connected enclosure that stays outside the mouth. The enclosure provides a light vibration.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

12 Years to 40 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Permanent dentition between the ages of 12 and 40

Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines

Good oral hygiene and compliance

Exclusion Criteria:

Any compromised medical or dental condition

Patient currently involved in any other study

Lives significantly outside San Antonio, TX

use of bisphosphonates

pregnant females

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830947